一批高端医疗器械列入优先审批目录

Core Viewpoint - The National Medical Products Administration (NMPA) has developed the "Priority Approval Directory for High-end Medical Devices (2025 Edition)," which includes medical electronic accelerators, implantable brain-machine interface medical devices, and endoscopic surgical control systems [1] Summary by Relevant Categories Regulatory Changes - The NMPA will implement priority approval for medical device registration applications listed in the directory according to Article 73, Item 3 of the "Regulations on the Registration and Filing of Medical Devices" [1] Approval Process - The Medical Device Technical Review Center of the NMPA will review the registration application materials for the products in the directory. If the review proposes priority approval, the results will be publicly announced, and if there are no objections, the application will enter the priority approval process [1] - If the review does not propose priority approval, the reasons will be communicated to the applicant, and the application will be processed according to standard procedures [1]